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Sarah W. Peters
Sarah W. Peters

Public Documents 1
How I Approach Ethical Considerations for Pediatric Phase I CAR T-cell Trials
Sarah W. Peters
Sara Silbert

Sarah W. Peters

and 6 more

November 22, 2024
Chimeric antigen receptor (CAR) T-cells have shown remarkable promise in children, adolescents and young adults with B-cell malignancies. Such outcomes have shifted expectations for all phase I CAR T-cell trials to be equally successful. The juxtaposition of high expectations, uncertain outcomes, and potential for life-threatening toxicities raises unique ethical challenges. To aid patients and providers considering enrollment on early phase CAR T-cell trials, we discuss: (1) considerations for enrollment of pediatric patients, (2) understanding trial intent and expectations, (3) weighing risks and benefits, (4) considerations for informed consent discussions, (5) post CAR T-cell therapy expectations, and (6) barriers to access.

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